Klaria initiates large-scale production of KL-00119 oral film (sumatriptan) for its clinical registration trial
The clinical trial is currently designed to last approximately 8-10 weeks. It will be followed by market registration submissions based on the full data file to regulatory authorities covering all important markets, including the EU and the US.
Together with the completion of the final clinical study, large-scale production involving the final market-ready packaging in volumes ranging up to 500,000 doses is the final step of the KL-00119development process. This will ensure Klaria’s ability to produce large quantities of a high-quality drug product to regulatory authorities and potential license partners. The final product must pass strict pharmaceutical quality controls and prove to be stable during the distribution process, on pharmacy shelves and in the hands of patients.
“We are pleased to announce the successful initiation of large-scale KL-00119 production that will satisfy the demand for our upcoming pivotal clinical trial. This is a major step towards gaining market authorization for all relevant markets, including the EU and the US. To ensure consistent quality and low cost of goods in the final marketed product, we have put a huge amount of effort into creating an optimal production process, including several feasibility studies at Adhex’s facilities. We are certain that this is appreciated by potential licensing partners, as the ability to satisfy global demand is expected to become a crucial factor for success when reaching the market,”says Klaria’s CEO Scott Boyer.
KL-00119 oral film (sumatriptan) is a completely new formulation of the leading substance for acute migraine treatment, with potential to simplify and significantly enhance the treatment of migraine attacks. The product is designed to attach firmly to the inner lining of the mouth, with a rapid and consistent delivery of the necessary sumatriptan dose without the need for injections, nasal sprays or tablets to be swallowed. For patients experiencing nausea prior to or during a migraine attack, KL-00119 will also eliminate the fear of vomiting the dose back up.
Klaria acknowledges funding for the KL-00119 project through the European Union’s Horizon 2020 research and innovation program under grant agreement number 829615.